ButCoIns GUTS: - Gut Immunological Effects of Resistant Starch and Arabinoxylans in Subjects With Metabolic Syndrome

University of Aarhus

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Dietary Supplement: Western Style Diet; Dietary Supplement: Healthy Carbohydrate Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01618526

V02062012

Details and patient eligibility

About

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.

In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are randomized to two types of diet intervention: a low and a high fiber diet. The participants are subjected to endoscopy before and in the end of each intervention.

Full description

Dietary fibers including resistent starch, RS, and arabinoxylans, AX, have been shown to have anti-inflammatory effects and to change the composition of the faecal micro flora in the colon.

In this unblinded dietary intervention cross-over study 20 subjects with metabolic syndrome are subjected to two types of diet intervention:

1. a western style diet, WSD, with a low fiber content and
2. a healthy carbohydrate diet, HCD, a high fiber diet. Between the two 4-weeks diet is a wash-out period of four to eight weeks. The participants are subjected to endoscopy with tissue samples before and in the end of each intervention. Fecal and blood samples will be collected at the same time.

We hypothesize that a high content of resistent starch and arabinoxylans increases colonic butyrate concentration, changes colon's mucosal immune system and the microbiota.

A small pilot study will be carried out on 12 healthy volunteers in order to obtain a reference to participants with metabolic syndrome. The healthy volunteers will be subjected to an endoscopy but no dietary intervention.

Enrollment: 22 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: At least 3 out of 5 following criteria:

• Central obesity (Female > 80 cm, Male > 94 cm)
• HDL cholesterol (Female < 1,03 mmol/L, Male < 1,29 mmol/L)
• Bloodpressure (> 130/85 mmHg)
• Fasting Blood Glucose > 5,6 mmol/L

Exclusion Criteria:

• Diabetes
• Gastrointestinal disease
• Serious liver, heart or kidney disease
• Anticoagulation treatment
• Anaemia
• Corticosteroid treatment
• Waist circumference above 130 cm
• Alcohol or drug addiction
• Pregnancy or lactation

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

22 participants in 2 patient groups, including a placebo group

Healthy Carbohydrate Diet

Active Comparator group

Description:

4 weeks of intervention with a diet rich in Arabinoxylans and Resistent Starch

Treatment:

Dietary Supplement: Healthy Carbohydrate Diet

Western Style Diet

Placebo Comparator group

Description:

4 weeks of intervention with a diet with low content of Resistent Starch and Arabinoxylans.

Treatment:

Dietary Supplement: Western Style Diet